On January 8, 2018, Hengrui Pharmaceutical entered into a license agreement with TG Therapeutics Company of the United States. Hengrui paid the royalty of BTK inhibitors SHR1459 and SHR1266 (code-named TG-1701 and TG-1702 respectively) with independent intellectual property rights to the United States TG Inc. This is the second paid licensee between Hengrui and foreign companies this year since Jan. 4. Since its listing in 2000, Hengrui has entered into licensing agreements with three U.S. companies, Heavy products out of the country? Over the years, the preparations listed in foreign markets, what?
Four major research new products to the world
Table 1: Details of the licensing agreement between Hengrui Pharmaceutical and three U.S. companies
(Source: Public Company Announcement)
PD-1 monoclonal antibody SHR1210
On September 1, 2015, Hengrui and American Incyte reached an agreement in the United States that Hengrui paid the licensed project of PD-1 monoclonal antibody (code SHR1210) for tumor immunotherapy with independent intellectual property rights to Incyte Corporation of the United States, Incyte acquires exclusive worldwide rights to clinical development and marketing beyond the Chinese mainland, Hong Kong, Macau and Taiwan.
Agreement, the United States Incyte company to pay the down payment of $ 25,000,000 Hengrui listed milestone payment, SHR1210 in the EU, the United States, Japan after the successful listing, the United States Incyte to Hengrui pay a total of not more than 90 million US dollars in milestone. Merit milestone payment, SHR1210 made excellent clinical trial results in foreign countries, the United States Incyte paid $ 150 million to Hengrui. Sales milestone payment, SHR1210 sales reached a similar goal, the United States Incyte company to pay Hengrui A total of not more than 530 million US dollars in milestone models.A sales commission, SHR1210 listed abroad, Hengrui in accordance with the agreed percentage from its annual sales commission.
According to 2015 annual report data, Hengrui Pharmaceutical has received the first payment of the agreement plus milestone amounted to 795 million US dollars.
Hengrui Pharma started the research and development of PD-1 monoclonal antibody in 2012. At present, the company has applied for the domestic patent and PCT international patent of SHR1210, and the product has been approved by the CFDA for clinical trials of new drugs. Incyte Company of the United States has promised to conduct clinical trial after signing the agreement test.
JAK1 small molecule inhibitor SHR0302
On January 4, 2018, Hengrui reached an agreement with Arcutis Corporation of the United States in the United States. Hengrui paid a license for JAK1 inhibitor (code: SHR0302) with independent intellectual property rights to the Arcutis Company of the United States For exclusive clinical development, registration and marketing rights in the United States, the European Union and Japan, SHR0302 is licensed for R & D and sales as topical topical formulations for the treatment of skin disorders.
Agreement, the United States Arcutis company in July 2017 to pay $ 100,000 to Hengrui for 3 months exclusive agreement to negotiate the agreement within 30 days after the signing of the agreement, the United States Arcutis will pay the down payment $ 400,000 from Hengrui from Arcutis will receive an 18-month evaluation period from the date of signing the agreement for the development of topical formulations and proof-of-concept tests for up to Phase IIa clinical trials. When Arcutis Inc. of the United States decided to formally introduce SHR0302, Arcutis would need to further Hengrui pay 1.5 million US dollars.
Development and listing milestone payment, Hengrui will receive 3 million U.S. dollars when SHR0302 enters the Arcutis Phase III clinical trial in the United States SHR0302 After the successful listing in the United States, the European Union and Japan, the U.S. Arcutis Company paid no more than 1,750 to Hengrui Milestone milestone sales milestone payments, SHR0302 sales reached 250 million to 1 billion US dollars more than the range of the United States Arcutis will pay Hengrui accumulated no more than 200 million US dollars in milestone, the amount of each goal Ranging from US $ 20 million to US $ 100 million In terms of sales proceeds, Hengrui receives a royalty from its sales in the agreed ratio of 6% to 12% after SHR0302 is listed in the United States, the European Union and Japan.
Currently, Hengrui has completed Phase I clinical trials among healthy Chinese subjects and is continuing to develop SHR0302 for oral autoimmune diseases in Phase II clinical trials. Arcutis will prepare the trial after the agreement is signed. It is reported that Hengrui can receive up to a total of 223 million U.S. dollars down payment and milestone models, plus sales commission.
BTK inhibitors SHR1459 and SHR1266
On January 8, 2018, Hengrui entered into a license agreement with TGTherapeutics Company of the United States. Hengrui paid the license of BTK inhibitors SHR1459 and SHR1266 (codenamed TG-1701 and TG-1702 respectively) with independent intellectual property rights to the U.S. TG Company TG will receive its exclusive clinical development and marketing rights to treat malignant hematologic tumors alone or in combination with drugs in areas outside Asia excluding Japan.
The agreement stipulated that within 90 days after the signing of the agreement, Hengrui can obtain a down payment of USD 1 million or equivalent shares of TG Company.
In developing and approving milestone payments, Hengrui will receive a cumulative total of no more than US $ 7.1 million in milestone or equivalent equity in TG Company, once each BTK inhibitor is in a different phase of clinical trials.When each BTK inhibitor and When other drugs to treat hematologic tumors are combined or when clinical trials in overseas prove superior to ibrutinib or alkalaitinib BTK inhibitors, Hengrui will receive approximately $ 38 million in milestone or equivalent TG Company Stake in each BTK inhibitor approval of the national permit, TG company to pay a total of no more than 48 million US dollars milestone milestone sales milestone payments, each BTK inhibitor sales reached 250 million to 10 In the interval of more than US $ 100 million, TG Company paid Hengrui a total amount of not more than US $ 80 million. Each target ranged from US $ 10 million to US $ 50 million.
As for the sales commission, after each BTK inhibitor is listed overseas, Hengrui receives a royalty from its sales amount in the agreed proportion, ranging from 10% to 12%.
In December 2017, Hengrui launched SHR1459 Phase I clinical trial in China for the treatment of hematological tumors. SHR1266 is currently in the pre-clinical development phase. TG will prepare for the trial after the agreement is signed and both parties will work together to promote the project's development And listing work.It is reported that Hengrui can receive about 347 million US dollars down payment and milestone models, plus sales commission.
12 preparations have been approved for sale in foreign markets
Table 2: Hengrui pharmaceutical approved for sale in foreign countries preparations
(Source: listed company announcement finishing, ★ for the announcement date)
Since its listing in 2000, Hengrui Pharmaceutical has continuously achieved outstanding achievements in the internationalization of formulation products.According to the announcement and annual report statistics of listed companies, Hengrui Pharmaceutical has successfully obtained the approval of irinotecan injection for sale in the United States since 2011, Confidence in overseas markets is on the rise. So far about 12 formulations have been successfully approved for sale in several countries.
According to the annual report data, Hengrui's revenue in overseas regions in 2016 exceeded 430 million yuan, with a growth rate of 21.47% and a gross profit margin of 91.41%. The internationalization of formulation products has greatly boosted the performance of the Company.
2017 is the year of internationalization of Hengrui's pharmaceutical products. ANDA, the three products of besylate cisatracurium injection, docetaxel injection and dexmedetomidine hydrochloride injection, is approved for listing in the United States. Caspofungin Acetate for Injection is approved by the Medicines and Health Products Authority of the United Kingdom and the Federal Drugs and Medical Devices of Germany approved for listing in the United Kingdom and Germany. The inhalation of desflora is approved by the written notice of the Food and Drug Administration of the United Kingdom, Germany and the Netherlands. The above preparations will be listed in the approved areas after sale, the company will bring even more satisfactory performance returns.
Conclusion Research reports that Hengrui strong R & D strength, and research product line is rich in the next three years will enter the 'innovation medicine + formulation export' harvest period, from the current data, 2017 is the harvest period Starting point.The company's international strategy is no longer just a formulation 'going out', there are two in 2018 the successful completion of the product license rights, but also to the company to bring new ideas and direction of development.With the company in overseas markets The layout of the gradual improvement and expansion, Hengrui future is expected to grow into an international pharmaceutical companies.
Note: The above statistics range from 2000 to January 12, 2018, the annual report of listed companies, announcements, if any omissions, please correct me.
